Label: PYRITHIONE ZINC shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 29, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • DOSAGE & ADMINISTRATION

    For maximum dandruff control, use every time you shampoo.
    Wet hair, massage unto scalp, rinse, and repeat if desired.

    For best results use at least twice a week or as directed by a doctor.

  • WARNINGS

    For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • INACTIVE INGREDIENT

    Aqua, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocoamide DEA, Acrylates/Steareth-20 Methacrylate Copolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Methylparaben, Propylparaben, Parfum, Polyquaternium-7, Phosphoric Acid, FD&C Blue 1/ CI 42090, Limonene.

  • INDICATIONS & USAGE

    Anti-Dandruff Shampoo Helps prevent recurrence of flaking and itching associated with dandruff.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of children’s reach.

  • PURPOSE

    Anti-dandruff

  • ACTIVE INGREDIENT

    Pyrithione Zinc 1%

  • PRINCIPAL DISPLAY PANEL

    10 OZ

  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80465-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80465-001-10283 g in 1 BOTTLE; Type 0: Not a Combination Product09/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03209/21/2020
    Labeler - EROS GLOBAL CORP (117597821)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(80465-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!